Pharmaceutical Grade Guar Gum | USP/NF Compliant Excipient

Pharmaceutical grade guar gum is a highly purified galactomannan (E412) manufactured under GMP-aligned controls and tested against USP/NF excipient monograph criteria. Compared with food grade, it carries tighter limits on heavy metals, microbial counts, protein and acid-insoluble residue, plus full batch traceability and a documented COA suitable for regulatory filings.

Guar gum has an official monograph in the USP/NF excipient compendium. B.D. Guar's pharmaceutical grade is manufactured and tested to those monograph parameters — identification, viscosity, loss on drying, residue on ignition, protein, heavy metals and microbial enumeration — and each lot ships with a COA referencing the test methods used.

Guar gum typically works as a wet-granulation or direct-compression binder at 2-5% w/w of the tablet mass. At the lower end it improves granule cohesion without over-hardening; at 4-5% it delivers robust crushing strength for friable actives. Because of its high hydration efficiency, guar generally binds at lower levels than starch paste or PVP.

Yes. At 20-40% w/w guar gum forms a hydrophilic matrix that swells on contact with gastric and intestinal fluid, creating a gel layer that governs drug diffusion. It is widely studied for once-daily oral matrices and, because colonic microflora degrade galactomannan, for colon-targeted delivery systems.

It can be both, depending on concentration. Below roughly 2-4% guar gum swells rapidly and acts as a disintegrant, promoting tablet break-up. Above that level the swollen gel becomes cohesive and it functions as a binder or, at high loadings, as a sustained-release matrix former.

Guar gum suspensions are most stable between pH 5.5 and 7.0 and tolerate short excursions from pH 4 to 10. Viscosity is stable at ambient storage; prolonged exposure to strong acid, high temperature or oxidising agents causes chain scission and viscosity loss. A preservative system is required for aqueous multi-dose products.

Guar gum is listed in the FDA Inactive Ingredient Database for oral dosage forms, is GRAS for food use, carries EU additive number E412, and appears in USP/NF and Ph. Eur. excipient monographs. Our facility is FDA registered and ISO 22000 certified, and we support customer filings with Drug Master File-style documentation packages.

Yes. We supply a documentation pack covering manufacturing flow diagram, raw material origin, elemental impurity risk assessment, residual solvent and ETO statements, TSE/BSE and allergen declarations, nitrosamine risk statement and stability data, plus DMF-style support letters for customers filing ANDA or dossier submissions.